Kornimate/medical-research-clean huggingface dataset:
a safety and tolerability study of pemigatinib in japanese subjects with advanced malignancies - (fight-102)

Conditions: Solid Tumors

Summary: the purpose of this study is to evaluate the safety and tolerability of pemigatinib in japanese subjects with advanced malignancies.


Eligibility criteria:
inclusion criteria: * first generation japanese; subject was born in japan and has not lived outside of japan for a total of \> 10 years and subject can trace maternal and paternal japanese ancestry. * part 1: any histologically confirmed advanced solid tumor malignancy. subjects enrolled at a lower dose level expansion cohort are required to have documented fgf/fgfr alterations and baseline and on-treatment tumor biopsy for testing of biomarkers. * part 2: any histologically confirmed advanced solid tumor malignancy with a fgf/fgfr alteration * advanced or metastatic and recurrent cancer where an appropriate treatment option is not available. * life expectancy \> 12 weeks. * eastern cooperative oncology group (ecog) performance status: part 1: 0 or 1; part 2: 0, 1, or 2. * genomic testing is mandatory for all enrolled subjects. archival tumor specimen of at least 7 slides or willingness to undergo a pretreatment tumor biopsy to provide a tumor block or at least 7 unstained slides. archival tumor biopsies are acceptable at baseline and should be no more than 2 years old (preferably less than 1 year old and collected since the completion of the last treatment); subjects with samples older than 2 years old and/or with sequencing report from the central laboratory require approval from the sponsor medical monitor for exemption from tumor biopsy or tumor sample requirement. exclusion criteria: * treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives (whichever is longer) before first dose of study drug (6 weeks for mitomycin-c or nitrosoureas, 7 days for tyrosine kinase inhibitors). * prior receipt of a selective fgfr inhibitor. * laboratory and medical history parameters outside protocol-defined range. * history and/or current evidence of ectopic mineralization/calcification including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification. * current evidence of corneal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmologic examination.

Keywords: solid tumor malignancy fibroblast growth factor receptor (fgfr) fibroblast growth factor (fgf)/fgfr alteration
boston scientific registry of deep brain stimulation for treatment of essential tremor (et)

Conditions: Essential Tremor

Summary: to compile characteristics of real-world outcomes for boston scientific corporation's commercially approved deep brain stimulation (dbs) systems, when used according to the applicable directions for use, for the treatment of essential tremor.

to compile characteristics of real-world outcomes using deep brain stimulation (dbs) for the treatment of essential tremor to add to the evidence available for treatment of et.

Eligibility criteria:
inclusion criteria: * meets criteria established in the locally applicable directions for use (dfu) for essential tremor * is at least 18 years old exclusion criteria: * meets any contraindication in locally applicable directions for use

Keywords: deep brain stimulation boston scientific essential tremor
comparison of intravenous co-amoxiclav versus benzyl penicillin

Conditions: Tonsillitis Streptococcal

Summary: to compare intravenous co-amoxiclav versus benzyl penicillin in children with severe streptococcal tonsillitis in terms of efficacy, safety and cost effectiveness.

efficacy was measured through improvement (decrease in fever, settling lymphadenopathy and disappearance of tonsillar exudate) in centor criteria score on daily basis. improvement i.e reduction in centor criteria score was recorded for all children till full recovery. safety was measured by frequency of hypersensitivity reactions or severe side effects of antibiotics necessitating stoppage of the drug. all the children in both groups were given test dose of the antibiotic before giving full dose of antibiotic prescribed. cost effectiveness was compared in terms of total cost of injections (co-amoxiclav versus benzyl penicillin) which were administered to children in both groups.

Eligibility criteria:
inclusion criteria: 1. children who had 3 or 4 score according to centor criteria for tonsillitis/pharyngotonsillitis, were included in study 2. children between ages of 5 to 15 years 3. children with positive rapid antigen detection test (radt) for streptococcus pyogenes exclusion criteria: 1. immunocompromised children 2. children with known hypersensitivity to penicillins (esp coamoxiclav and benzyl penicillin) 3. children with liver or renal failure 4. children who were already using any oral or parenteral antibiotics

Keywords: co-amoxiclav benzyl penicilli tonsillitis
lymphangioleiomyomatosis, a study on cathepsin k

Conditions: Lymphangioleiomyomatosis; Tuberous Sclerosis Complex

Summary: this is a physiopathological case-control, non-interventional, monocentric study of adult patients with lymphangioleiomyomatosis. the controls are patients followed in neurology at the chu of tours for a tuberous sclerosis complex without lymphangioleiomyomatosis, the healthy volunteers are women with neither pulmonary nor renal pathology and recruited at the clinical investigation centre of the chu of tours.


Eligibility criteria:
inclusion criteria for patients with lymphangioleiomyomatosis * age ≥ 18 years * female carrier of lymphangioleiomyomatosis according to ers criteria inclusion criteria for healthy female volunteers * age ≥ 18 years * women with no history of lymphangioleiomyomatosis, pulmonary, renal or osteoporotic disease inclusion criteria for tuberous sclerosis complex patients without lymphangioleiomyomatosis * age ≥ 18 years * woman followed for tuberous sclerosis complex for whom a chest ct scan less than 3 years old does not objectify a pulmonary cyst. (= without lymphangioleiomyomatosis) non-inclusion criteria * woman under judicial protection * woman with a urinary tract infection within 15 days * person who objected to the data processing

Keywords: urine
the clinical efficacy of rezūm therapy versus bipolar trans-urethral resection of the prostate for treatment benign prostatic hyperplasia

Conditions: Prostatic Hyperplasia

Summary: we aimed to compare the efficacy and safety of rezūm therapy and bipolar transurethral resection of prostate (b-turp) for the management of benign prostatic hyperplasia (bph) of 50-120gm size.

for decades, transurethral resection of the prostate (turp) was the gold standard surgical intervention for small and moderate prostates, however it has high morbidity and prolonged hospital stay. in contrast to monopolar turp (m-turp), where prolonged resection carries the risk of transurethral resection (tur) syndrome, bipolar transurethral resection of prostate (b-turp), especially in large prostates was a promising procedure for urologists, but unfortunately, the morbidity rate of b-turp remains high \[4\]. therefore, newer minimally invasive procedures have been introduced to provide alternative surgical options to turp. rezūm is a radiofrequency made water vapour thermal treatment. it has recently been added to the international guidelines as a choice for medical treatment resistant lower urinary tract symptoms (luts). the aua and canadian urological association (cua) guidelines now add water vapour therapy as a treatment option for bph patients with small prostate size \<80 gm and for those wishing to maintain antegrade ejaculation. while they still offer no clear recommendation to rezūm use for those with large prostates. early studies on this topic have found out promising results.

Eligibility criteria:
inclusion criteria: * patients aged 50-80 years * prostate volumes of 50-120 ml * sexually active * severe luts * \[q max\] of \<10 ml/s * \[ipss\] of \>20) * failed medical treatment with alpha blockers exclusion criteria: * prostate cancer * neurogenic bladder * urethral stricture * urinary bladder stone * previous prostatic surgery.

Keywords: rezum luts b-turp
effectiveness of a jaw exercise program in temporomandibular disorders patients

Conditions: Temporomandibular Joint Disorders; Musculoskeletal Diseases

Summary: this study evaluates the effect of jaw exercise therapy in the treatment of temporomandibular disorder patients (tmd). an eligible group of patients will be treated with that therapy (experimental group) and another group will be treated with counseling and occlusal splint (control group), considered the standard therapy for tmd.

mandibular exercises may have behavioral and cognitive action, educating the patient and serving as an instrument of control of parafunctional activity. it is a simple, easy, which seeks adherence to treatment and has negligible cost. a disadvantage is the need of motivation and discipline of the patient in carrying out the therapy daily. the occlusal splints, associated with educational guidance and counseling have world indication the possibility of promoting teeth protection, joint decompression, equalization of electromyographic activity, conscious control of parafunctional activity and strong placebo effect.

Eligibility criteria:
inclusion criteria: * females, aged 20-45 years, clinical diagnosis of muscular tmd form mild to moderate according to the criteria of the diagnostic and research of tmd (rdc / tmd), good reception and understanding of spoken portuguese, able to provide a informed consent, and be available to attend the evaluation returns. exclusion criteria: * rheumatic, vascular, neurological, infectious or neoplastic disease, cognitive or motor problems, pregnancy status or use of abusive drugs, chronic facial pain history (2 years or more), refuses to participate in the study.

Keywords: jaw exercise occlusal splint treatment muscular pain mandibular movement
manual dexterity control after cerebellar stimulation

Conditions: Stroke

Summary: this study will assess the putative advantages of cerebellar stimulation on motor learning abilities of stroke patients. in order to have a control group to refer to, the effect of cerebellar stimulation on healthy young and old participants will also be assessed.

cerebrovascular accidents (cva) are the first cause of acquired disability in france. despite rehabilitation interventions, a great proportion of patients suffers from motor disability in the upper limb. recently, several studies have shown that post cva patients exhibit great neural plasticity as a direct consequence of their condition. interestingly, the transcranial direct current stimulation (tdcs) is a non-invasive electro stimulation technique that allows for a modulation of cerebral activity. it has been shown that when applied to the cerebellum, tdcs increases learning performances of healthy subjects. yet, motor rehabilitation after a cva highly relies on motor (re)learning. the cerebellar tdcs thus appear as a promising method to enhance the performance of post-cva motor learning and consequently the benefits of post-cva rehabilitation. the current study aims to promote the post cva neural plasticity by using the tdcs in order to enhance motor learning of the upper limb.

Eligibility criteria:
inclusion criteria: * right-handed * affiliated to the french health insurance or similar organisation * signed informed consent * clinical examination for "post-avc patients" : * at least 18 years old * completed the moberg pick-up test with a minimum score of 20 secondes for "young healthy" group * 18 = or \> years = or \<30 for "older healthy" group * 50 \> or = years = or \< 80 exclusion criteria: * metallic implant in the head * pacemaker, or other electronic implanted devices * other central neurological disease * pregnancy, breast feeding * previous history of neurosurgery or seizures or 1st degree relative with history of seizures * history of medical neurological or psychiatric disorders * participation to another study using cerebral stimulation * history of bi-polar or recurring depressive disorders * planned carotid revascularization, severe caridac disease * kidney failure (transaminase \> 2 times normal value) * other invalidating condition or deficiency interfering with the study for "post-avc patients" : * nihss score \> 20 * cerebellar ischemic cva

Keywords: motor learning stroke tdcs upper limb
dalacin-t gel post approval study

Conditions: Acne Vulgaris

Summary: to investigate, in a comparison vs. acuatim cream (nadifloxacin cream), the efficacy and safety of dalacin t gel (clindamycin phosphate gel) as a therapeutic medication for acne vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify the clinical positioning of dalacin t gel.


Eligibility criteria:
inclusion criteria: * acne vulgaris patients found by a investigator to have at least 10 inflammatory lesions (papules, pustules) on a portion of either a cheeks or the forehead, with an inflammation severity of moderate or worse. exclusion criteria: * patients with, for example, acne elastosis, steroidal acne, necrotizing acne, or occupational acne.
a need-based nutritional intervention in nursing home residents

Conditions: Malnutrition

Summary: to examine the effectiveness of a "need-based nutritional intervention" strategy in improving the nutritional and physical functional status of nursing home elderly.

ninety-two nursing home residents aged 65 years or older and bmi \<25 were randomly assigned to the intervention or control groups. subjects in the treatment group received a soy-protein-based nutritional supplement, if his/her bmi was \<24kg/m2 and nutritional score was \<24 according to the mini nutritional assessment. the supplementation would be suspended if both conditions were not met. at baseline and every 4 weeks up to 24 weeks, thereafter, all subjects were measured for anthropometric parameters. at baseline, 12 weeks and 24 weeks subjects were measured for blood biochemical indicators, handgrip strength and barthel's index.

Eligibility criteria:
inclusion criteria: 1. ≥ 65 years of age 2. bmi ≤ 25 (kg/m2) 3. ≥1 month of residency 4. able to self-feed or receive oral-feeding 5. non-bed-ridden 6. cognitively able to answer the questionnaire exclusion criteria: 1.hospitalized or having acute infection/diseases

Keywords: nutritional supplement nutritional status physical functional activity nursing home elderly
progressive open angle glaucoma (oag) and ocular blood flow

Conditions: Open Angle Glaucoma

Summary: the purpose of this study is to assess the correlation of vascular parameters, including genetic factors as well as ocular blood flow parameters against the progression rate of glaucomatous damage in patients with progressive oag.

glaucoma is one of the most common causes of blindness in the industrialized nations. for a long time glaucoma has been defined as a disease in which high intraocular pressure (iop) leads to irreversible optic disc damage and subsequent visual field loss. however, recent investigations show that iop is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. the role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. genes with products that are involved in the regulation of blood flow to ocular tissues may also be considered plausible candidates as a contributory factor in the development of glaucoma. little is, however, known about a potential association between glaucomatous optic neuropathy and glaucomatous visual field defects and optic nerve head blood flow in patients with progressive open angle glaucoma (oag). the current study seeks to gain insight into this association by assessing ocular blood flow parameters with a number of noninvasive technologies.

Eligibility criteria:
inclusion criteria: * men and women over 40 years * unilateral or bilateral primary open angle glaucoma (poag) or normal tension glaucoma (ntg) with visual defect, marked by an agis score (1994; 1. study design and methods and baseline characteristics of study patient) of at least 1 but not more than 16 at the screening visit * at least 3 reliable visual field tests in the eye that will be studied * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * best-corrected visual acuity of 20/40 or better, spherical refraction within ± 3.0 diopters and cylinder correction within ± 3.0 diopters exclusion criteria: * evidence of secondary glaucoma, pseudoexfoliation, pigmentary dispersion * any form of retinal or neuroophthalmological disease that could result in visual field defects. * mean iop \> 30 mmhg, or any iop \> 35 mmhg in at least one eye * history of acute angle closure * closed or barely open anterior chamber angle * topical or systemical/oral therapy with steroids * standard deviation of visual field testing \> 10 * ocular inflammation or infection within the last three months * intraocular surgery or argon laser trabeculoplasty within the last six months * regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug * symptoms of a clinically relevant illness in the 3 weeks before the first study day * blood donation during the previous 3 weeks * ametropia \> 3 dpt

Keywords: genetic vascular risc factors ocular blood flow progressive glaucoma
alleged drug allergies in military general medicine: patients' experiences and beliefs

Conditions: Allergy Penicillin

Summary: this study focuses on the experience of the military patient reporting a suspected drug allergy, with its own specificities. suspicions of drug allergies during a mission expose the doctor to difficulties. this study will improve understanding of the allergy patient's point of view. the end result could be a set of ideas for measures to raise awareness among these patients, and motivate them to undergo an allergological assessment.


Eligibility criteria:
inclusion criteria: * military personnel (active or reservist) * reporting a drug allergy during a periodic medical check-up or during a consultation in a medical unit * not opposed to participating in the study. exclusion criteria: * candidate on admission visit * opposition to study * minor (under 18 years of age) * pregnant, parturient or breast-feeding woman * person deprived of liberty by a judicial or administrative decision, person under psychiatric care * non-french nationals * person of full age subject to a legal protection measure * person unable to express non-opposition
comparison trial of letrozole to anastrozole in the adjuvant treatment of postmenopausal women with hormone receptor and node positive breast cancer

Conditions: Breast Cancer

Summary: eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.


Eligibility criteria:
inclusion criteria: * recent primary surgery for breast cancer * early stage breast cancer * postmenopausal * hormone receptor positive * positive lymph node involvement exclusion criteria: * metastatic disease * presence of contralateral breast cancer including dcis * progression other protocol-defined inclusion/exclusion criteria may apply.

Keywords: breast cancer letrozole anastrozole adjuvant postmenopausal face
nutrition care process in mexican older adults

Conditions: Malnutrition

Summary: the aim of this clinical trial is to determine the efficacy at 12 months of the application of the nutrition care process in the eating habits of older adults in the state of colima, mexico compared to a conventional nutritional intervention. the main questions it aims to answer is: what is the efficacy of the application of the nutrition care process vs. a conventional nutritional intervention on the eating habits of older adults in the state of colima, mexico after 12 months of follow-up?

participants will be two study groups. group 1 will apply the nutritional care process and group 2 will use standard care. the structured survey of food quality of the older adult will be applied to classify eating habits as good and bad; as well as the reduction of malnutrition in the study participants, in addition, the 24-hour reminder and the food consumption frequency questionnaire will be evaluated before and after the nutritional intervention, an eating plan will be determined according to the needs and later, follow-up will be given for 8 weeks, finally monitoring will be done at 3, 6 and 12 months in order to detect changes in eating habits. the financial resources will be financed by resources own in the social coexistence center for the older adults in the metropolitan area of colima, mexico. group experience: there are health professionals specialized in patient care. the protocol has the approval of a local research ethics committee (ceicancl220223-nutricia-02).

Eligibility criteria:
inclusion criteria: * older adults ≥ 60 years old * female or male * who voluntarily agree to participate in the study. exclusion criteria: * people who have a specific treatment determined by another health professional * people with chronic kidney disease and hemodialysis or dialysis treatment. * adherence less than 80% in the nutritional intervention * incomplete data collection, participants who decide to leave the project * people who are hospitalized or die.

Keywords: nutrition care process older adults malnutrition eating habits
comparative clinical trial of lornoxicam to diclofenac in patients of osteoarthritis of knee joint.

Conditions: Osteoarthritis of Knee Joint

Summary: the purpose of this study was to compare the pain relieving action of the lornoxicam and diclofenac in patients of oa knee.


Eligibility criteria:
inclusion criteria: * newly diagnosed patient aged between 25 to 65 yrs of either gender suffering from osteoarthritis of knee according to criteria given by american college of rheumatology * informed consent obtained from the patient. exclusion criteria: * patients with any other systemic llness, * patients with pregnancy and lactation, * patients taking other drugs like lithium\[4\], digoxin, methotrexate, anticoagulants, antidiabetics, diuretics, * patients with h/o hypersensitivity to nsaids, * patients who had consumed any analgesics in last 1 month